A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

Trial Information

A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

This is a randomized (the study medication is assigned by a random order), active control
(study medication will be compared with available standard care of treatment),
parallel-group (each treatment group will be treated simultaneously at the same time and
each participant only receives one treatment regimen as assigned), open-label (both the
investigator and the participant know the intervention received by the participant),
multicenter study designed to determine if women with locally advanced or metastatic breast
cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant
(administration of treatment before surgery) or adjuvant setting (administration of
treatment after surgery), and who also had a disease-free interval of at least 12 months
since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL to
docetaxel therapy. Approximately 751 participants will be randomly assigned to either
receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy. Treatment is
to continue until disease progression or the occurrence of unacceptable treatment related
toxicity. Safety evaluations will include assessments of adverse events which will be
recorded from the first study related procedure until 30 days after the last dose of
medication; clinical laboratory tests and tests for cardiac function (multiple gated
acquisition scan/echocardiogram and electrocardiogram) which will be monitored throughout
the study.

Inclusion Criteria:

- Females with locally advanced or metastatic breast cancer who received prior
anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a
12-month disease-free interval since the end of their last cytotoxic therapy, were
eligible for the study

- Participants who received prior hormonal therapy, or no more than 1 cytotoxic
chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not
permitted), or both for advanced disease

- Participants with normal cardiac function, as evidenced by a normal left ventricular
ejection fraction

Study Design:

Outcome Measure:

Outcome Description:

Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.

Outcome Time Frame:

From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled

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